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P374 Efficacy of a micronised, dispersible ferric pyrophosphate in children with anaemia associated with inflammatory bowel disease.

A. Wegner*1, G. Mierzwa2, S. Wiecek3, A. Korlatowicz- Bilar4, M. Dadalski5, B. Korczowski6, J. Kierkus7

1Public Children’s Clinical Hospital, Warszawa, Poland, 2Nicolaus Copernicus University Collegium Medicum in Bydgoszcz, Chair of Vascular and Internal Diseases,, Bydgoszcz, Poland, 3Medical University of Silesia, Department of Paediatrics,, Katowice, Poland, 4Children’s Hospital, Department of Paediatrics, Gastroenterology and Rheumatology, Szczecin, Poland, 5Children’s Memorial Health Institute, Department of Gastroenterology, Hepatology and Eating Disorders,, Warsaw, Poland, 6University of Rzeszów, Department of Paediatrics and paediatric Gastroenterology State Hospital No 2, Rzeszów, Poland, 7Children’s Memorial Health Institute, Department of Gastroenterology, Hepatology and Eating Disorders, Warsaw, Poland

Background

Anaemia is one of the most frequent complications of inflammatory bowel disease (IBD) in children. Iron deficiency is the most important cause of anaemia in Crohn’s disease and ulcerative colitis patients. Oral iron supplementation is the main form of the treatment for anaemia in IBD. However, this treatment is associated with the high risk of side effects. In addition to that, oral iron may exacerbate the inflammation of the intestinal tissues.

Methods

The aim of the study was to assess the therapy efficacy and the frequency of side effects in patients with the anaemia during IBD, treated the ferric pyrophosphate. A prospective, randomised, multicentre trial was conducted in a group of 37 children (15 girls and 21 boys) aged 13.54 ± 2.7 years (mean ± SD), with inflammatory bowel disease (19 Crohn’s disease and18 ulcerative colitis) and iron deficiency anaemia. The patients were randomly assigned to start treatment with the micronised, dispersible ferric pyrophosphate in the dose 60 mg (group 1) or micronised, dispersible ferric pyrophosphate in the dose 120 mg (group 2) for a period of 90 days. Clinical disease activity assessment and blood analysis were performed on days 0 and 90 of the trial.

Results

In total, 34/37 patients completed the study.

During the trial the haemoglobin, haematocrit, ferritin and TIBC scores were increased in both groups with statistical significance (p < 0.05). The iron level was increased with statistical significance in group 2 but not in group 1.

Table 1. Laboratory results, group 1

Group 1Day 0Day 0Day 90Day 90
MeanSDMeanSD
Haemoglobin11.420.9212.131.33
Haematocrit34.82.537.053.72
Ferrum40.7328.6455.7644.27
Ferritin16.8223.9921.4319.55
TIBC368.36114.11309.5755.88

Table 2. Laboratory result, group 2

Group 2Day 0Day 0Day 90Day 90
MeanSDMeanSD
Haemoglobin11.671.412.661.35
Haematocrit35.583.9938.54.18
Ferrum43.5222.7572.0734.37
Ferritin13.278.0824.5918.24
TIBC333.1151.25277.2377.45

There were no statistical significant differences in comparison this parameters from group 1 and 2 in the 90 trail day.

During the trial there were no SAE. 13 patients from group 1 reported the side effects (7 stomach ache; 3 nauseas; and 2 constipation). In group 2, 7 patients reported the side effects (3 stomach ache; 3 nauseas; and 1 constipation). The difference between groups was not statistically significant.

Further, 3 patients did not complete the trial. Reasons for not completing the study were withdrawal of consent (1 patient from group 2), relapse of the disease, and cessation of ferric pyrophosphate (1 patient from group 1 and 1 patient from group 2).

Conclusion

Ferric pyrophosphate is effective and safe in children with IBD anaemia.